Tracheal catheter system for emergency airway management

Abstract

The invention discloses a tracheal catheter system for emergency airway management, which relates to the technical field of medical instruments, and comprises a bronchofiberscope insertion part for guiding the system into a trachea under a visual condition; the connecting frame is used for fixing and positioning each module; the catheter skeleton is made of a biocompatible material with a shape memory characteristic, is preferably a net-shaped structure formed by weaving hyperelastic nitinol alloy wires, and has a radial compression state and a radial expansion state; the release line is connected with the catheter skeleton and used for triggering radial expansion of the skeleton; the first magnetic attraction assembly is arranged at the near end of the catheter skeleton; the air bag is filled and used for achieving sealing in the trachea, the effective ventilation time is shortened by 40%-60%, and the occupied time of the bronchofiberscope is shortened by more than 80%. Specifically, the time from bleeding to effective ventilation establishment can be controlled within 30 seconds, the magnetic attraction modular assembly process only needs 5-10 seconds, the bronchofiberscope can be released within 1 minute after ventilation establishment, and precious time is won for subsequent rescue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a tracheal tube system for emergency airway management, which is particularly suitable for rapid airway establishment in cases of visual loss such as acute massive bleeding during fiberoptic bronchoscopy. Background Technology

[0002] Fiberoptic bronchoscopy (FBC) is a core tool in the diagnosis and treatment of respiratory diseases, widely used in the diagnosis and interventional treatment of conditions such as pulmonary shadows, hemoptysis, and airway stenosis. However, the bleeding risk inherent in the procedure, especially fatal massive hemorrhage, remains a serious challenge in clinical practice. International and domestic consensus defines massive hemorrhage associated with fiberoptic bronchoscopy as "acute bleeding in the lower respiratory tract with a single hemorrhage volume ≥100 ml". This type of bleeding is rapid and can overwhelm the glottis and main bronchus within tens of seconds, causing the patient to quickly fall into a state of suffocation. Although the overall incidence is about 0.1%-5%, the mortality rate is extremely high once it occurs.

[0003] Currently, there are significant clinical challenges in the emergency management of acute massive bleeding during bronchoscopy: Traditional laryngoscopic endotracheal intubation: When blood completely obscures the field of vision, the laryngoscope cannot expose the glottis, and intubation becomes a blind probe. Under difficult airway conditions, the success rate of traditional laryngoscopic intubation is significantly reduced, and repeated attempts will delay rescue opportunities and aggravate airway damage.

[0004] Fiberoptic bronchoscopic intubation: Although a visual technique, in cases of active massive bleeding, the lens is instantly covered by blood, completely losing visibility. Furthermore, standard procedure requires withdrawing the fiberoptic bronchoscope from the endotracheal tube, a cumbersome and time-consuming process. More importantly, the bronchoscope remains occupied until the patient is stably transported, posing a severe resource constraint in the management of high-risk bleeding patients.

[0005] Limitations of advanced resuscitation measures: techniques such as double-lumen tubes, bronchial occlusion balloons, and even extracorporeal membrane oxygenation (ECMO) have high technical requirements and long preparation times, making them unsuitable as first-line, universal emergency treatment options.

[0006] A fundamental contradiction exists in current technology: while fiberoptic bronchoscopes are ideal guiding tools for establishing difficult airway access, the traditional endotracheal tubes they guide can themselves "trapped" the bronchoscope, preventing its rapid withdrawal in emergencies for subsequent treatment or use on other patients. Furthermore, the rigid structure of traditional endotracheal tubes is prone to injury when passing through tortuous or narrow airways. Studies show that the incidence of airway injury related to endotracheal intubation can reach 15%-20%, with tube-airway mismatch being the main risk factor.

[0007] Therefore, those skilled in the art have provided an endotracheal tube system for emergency airway management to address the problems mentioned in the background art. Summary of the Invention

[0008] To address the shortcomings of existing technologies, this invention provides a tracheal tube system for emergency airway management, solving the problems mentioned in the background section.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a tracheal tube system for emergency airway management, comprising a fiberoptic bronchoscope insertion section for guiding the system into the trachea under visual guidance; a connecting frame for fixing and positioning the various modules; a tube skeleton made of a biocompatible material with shape memory properties, preferably a mesh structure woven from superelastic nickel-titanium alloy wire, having radial compression and radial expansion states; a release line connected to the tube skeleton for triggering radial expansion of the skeleton; a first magnetic suction component disposed at the proximal end of the tube skeleton; and a filling gas... The system comprises: a cuff for sealing within the trachea; an airway connecting to the cuff for inflation and deflation; a first connecting tube for connecting the cuff module to the tubing frame; a second magnetic closure assembly located at the distal end of the cuff module and matching the first magnetic closure assembly; a connecting tubing for connecting the cuff module to an external breathing device; a second connecting tube for connecting the cuff module to the connector module; a third magnetic closure assembly located at the proximal end of the cuff module; a fourth magnetic closure assembly located at the distal end of the external connector and matching the third magnetic closure assembly; and an external connector with a standard 15mm ventilator interface.

[0010] As a further technical solution of the present invention, the catheter skeleton is radially compressed and fixed to the outer surface of the bronchoscope insertion part in the initial state, and the outer diameter after compression is 3-5mm.

[0011] As a further technical solution of the present invention, the release line extends from the distal end to the proximal end of the duct skeleton. Pulling the line can release the restraint, allowing the skeleton to expand radially in situ within the trachea to a preset diameter of 7.0-8.5 mm.

[0012] As a further technical solution of the present invention, the first magnetic attraction component and the second magnetic attraction component are connected to prevent misalignment by asymmetrically arranged permanent magnets, and the connection force is 5-10N.

[0013] As a further technical solution of the present invention, the filling airbag is designed with low pressure and high volume, and the material is medical-grade polyurethane or silicone.

[0014] As a further technical solution of the present invention, the austenitic phase transformation end temperature (Af) of the catheter skeleton is set at 34°C-36°C to ensure that it expands spontaneously under the action of body temperature after entering the airway.

[0015] As a further technical solution of the present invention, the porosity of the catheter skeleton is 30%-50%, which allows for the management of secretions while ensuring ventilation.

[0016] As a further technical solution of the present invention, the system also includes a restraint mechanism for fixing the compressed skeleton to the bronchoscope. The restraint mechanism is made of a biodegradable material or is achieved by mechanical locking.

[0017] As a further technical solution of the present invention, after the external connector is connected to the third magnetic component, it inflates the filling airbag through the air passage to achieve air tube sealing.

[0018] This invention provides a tracheal tube system for emergency airway management, which has the following advantages compared with the prior art: 1. Significant Time Efficiency: Compared with traditional fiberoptic bronchoscope-guided intubation, the system of this invention reduces the time to establish effective ventilation by 40%-60%, and the time spent using the fiberoptic bronchoscope is reduced by more than 80%. Specifically, the time from the onset of bleeding to the establishment of effective ventilation can be controlled within 30 seconds, the magnetic modular assembly process takes only 5-10 seconds, and the fiberoptic bronchoscope can be released within 1 minute after ventilation is established, gaining valuable time for subsequent rescue.

[0019] 2. Significantly Improved Safety: Experiments show that compared to traditional endotracheal tubes, the system of this invention reduces resistance by 65% ​​when passing through the glottis and trachea; histological examination confirms a 70% reduction in tracheal mucosal injury scores. This improved safety is mainly due to: the progressive expansion of the mesh framework reducing shear damage caused by the "forced passage" of traditional tubes; the adaptive expansion characteristics of the shape memory alloy allowing it to conform to the individualized anatomy of the patient; and the porosity of the mesh structure (designed to be 30%-50%) allowing partial passage of secretions while ensuring ventilation, thus reducing the risk of blockage.

[0020] 3. Simplified operation and short learning curve: In simulation training, even untrained medical personnel can assemble the system within 30 seconds after three practice sessions, while traditional fiberoptic bronchoscope-guided cannulation requires specialized training. The error-proof design of the magnetic docking system (asymmetric magnetic pole arrangement, ±15° tolerance angle, 5-10N docking force) supports "blind operation," allowing operators to complete accurate docking even in conditions of complete visual loss or poor lighting, through tactile and auditory feedback.

[0021] 4. Optimized resource utilization: The immediate deployment of the bronchoscope increases its turnover rate by 3-4 times, offering significant advantages in scenarios involving multiple injuries, mass casualties, or situations requiring multiple airway management. The withdrawn bronchoscope can be immediately cleaned and used for subsequent examinations on other patients or the same patient, significantly improving the utilization efficiency of this valuable medical equipment.

[0022] 5. Wide range of applications: The system of this invention is not only suitable for the emergency treatment of acute massive bleeding during fiberoptic bronchoscopy, but also for: elective surgery with anticipated difficult airways (providing a "reversible" endotracheal intubation solution, with control lines enabling partial retraction of the skeletal structure for easy extubation); pre-hospital emergency care and transport (miniaturized components, operation not dependent on ideal lighting conditions); patients with severe maxillofacial trauma and anatomical deformities; and resource-limited scenarios such as primary hospitals and war trauma. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of a tracheal tube system for emergency airway management; Figure 2 for Figure 1 A magnified structural diagram at point A; Figure 3 for Figure 1 A partial three-dimensional structural diagram; Figure 4 for Figure 3 A schematic diagram of the structure viewed from below; Figure 5 This is a schematic diagram of the cross-sectional structure of the duct skeleton.

[0024] In the diagram: 1. Fiberoptic bronchoscope insertion section; 2. Connecting frame; 3. Catheter skeleton; 5. Release line; 6. First magnetic suction assembly; 7. Inflatable cuff; 8. Ventilation tubing; 9. First connecting tube; 11. Second magnetic suction assembly; 12. Connecting catheter; 13. Second connecting tube; 14. Third magnetic suction assembly; 15. Fourth magnetic suction assembly; 16. External connector. Detailed Implementation

[0025] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0026] Please see Figure 1-5 The present invention provides a technical solution for an endotracheal tube system for emergency airway management, comprising a fiberoptic bronchoscope insertion part 1, a connecting frame 2, a tube skeleton 3, a release line 5, a first magnetic suction assembly 6, a filling airbag 7, an airway 8, a first connecting tube 9, a second magnetic suction assembly 11, a connecting tube 12, a second connecting tube 13, a third magnetic suction assembly 14, a fourth magnetic suction assembly 15, and an external connector 16.

[0027] The fiberoptic bronchoscope insertion section 1 is a standard fiberoptic bronchoscope insertion tube used to guide the entire system into the patient's trachea under visual guidance. During the preparation phase, the catheter skeleton 3 is radially compressed and fixed to the outer surface of the fiberoptic bronchoscope insertion section 1, forming a "guidewire-like" guiding structure.

[0028] The catheter framework 3 is made of a mesh structure woven from superelastic nickel-titanium alloy wire, possessing shape memory properties. Through a specific heat treatment process, its austenitic phase transformation end temperature Af is set to 34°C-36°C, ensuring that the framework can spontaneously expand from a radially compressed state to a radially expanded state under the influence of body temperature after entering the human airway. A first magnetic attraction component 6 is provided at the proximal end of the catheter framework 3 for docking with subsequent modules.

[0029] Release line 5 extends from the distal end to the proximal end of catheter skeleton 3. The operator can pull release line 5 to release the radial restraint on catheter skeleton 3 and trigger the dilation process.

[0030] The airbag module consists of an inflatable airbag 7, a ventilation tube 8, a first connecting tube 9, a second magnetic traction assembly 11, a connecting conduit 12, and a second connecting tube 13. The second magnetic traction assembly 11 is located at the distal end of the airbag module and matches the first magnetic traction assembly 6; the third magnetic traction assembly 14 is located at the proximal end of the airbag module and is used to connect with the external connector 16. The inflatable airbag 7 is designed for low pressure and high capacity, and is made of medical-grade polyurethane or silicone. It is inflated and deflated through the ventilation tube 8.

[0031] The distal end of the external connector 16 is provided with a fourth magnetic component 15, which matches the third magnetic component 14, and its proximal end is provided with a standard 15mm ventilator interface for connecting respiratory support equipment.

[0032] The catheter framework 3 is made of superelastic nickel-titanium alloy wire with a diameter of 0.15-0.25 mm using a double-layer interlaced braiding method. This braiding method provides good radial support and axial flexibility. After braiding, the austenitic phase transformation end temperature Af is set to 35°C ± 1°C through a heat treatment process. After electrochemical polishing, the framework surface is coated with a medical silicone coating with a thickness of 5-10 μm to reduce the surface friction coefficient and improve biocompatibility.

[0033] The magnetic assemblies, namely the first magnetic assembly 6, the second magnetic assembly 11, the third magnetic assembly 14, and the fourth magnetic assembly 15, are made of neodymium iron boron permanent magnets and plated with nickel or gold to ensure biocompatibility. The magnets are arranged in a ring-shaped asymmetrical pattern to ensure a unique and correct docking orientation.

[0034] The inflatable cuff 7 and the ventilation tubing 8 are made of medical-grade polyurethane or silicone material, and are designed for low pressure and high volume, compatible with commercially available endotracheal tube cuff systems.

[0035] Example 1: Management of acute massive bleeding during bronchoscopy Scene description: A 68-year-old male patient underwent a bronchoscopic biopsy for a lung lesion. During the procedure, he suddenly experienced massive bleeding, completely lost his field of vision within 3 seconds, and his blood oxygen saturation rapidly dropped to 82%.

[0036] Operating steps: 1) The operator should immediately stop the biopsy procedure and keep the bronchoscope in place; 2) The assistant quickly hands over a spare fiberoptic bronchoscope system with a pre-installed compression frame; 3) The operator keeps the bronchoscope stable, and the assistant completes the magnetic assembly of the balloon module and the external connector within 10 seconds, confirming the correct docking through tactile and auditory feedback; 4) The surgeon pulls the release line 5 and feels a slight "sense of relief", indicating that the skeletal restraints have been released; 5) After 15 seconds, manually ventilate by connecting the breathing bag through the external connector 16. The patient's chest can be seen rising and falling, and the blood oxygen saturation begins to rise. 6) After confirming effective ventilation, the operator withdraws the bronchoscope from the central lumen of the formed catheter. A large amount of blood can be seen under the bronchoscope, but the catheter skeleton is in good position. 7) The removed bronchoscope should be cleaned immediately in preparation for possible reuse or use on other patients.

[0037] Evaluation of effectiveness: The time from the onset of massive hemorrhage to the establishment of effective ventilation was less than 30 seconds. The bronchoscope was deployed within 1 minute after ventilation was established, which bought valuable time for subsequent rescue.

[0038] Example 2: Elective surgery for anticipated difficult airways Scenario description: A 45-year-old female patient with a history of ankylosing spondylitis and extremely poor cervical spine mobility. Preoperative assessment indicated a difficult airway, requiring thoracic surgery.

[0039] Operating steps: 1) Before anesthesia induction, while the patient is awake and sedated, the fiberoptic bronchoscope pre-loaded with the system of this invention is gently inserted into the trachea and accurately positioned under visual guidance. 2) Maintain the patient's spontaneous breathing and complete the magnetic assembly of the airbag module and external connector under conscious sedation; 3) After anesthesia induction, the operator pulls the release line 5 to trigger the in-situ expansion of the catheter framework 3 in the trachea to establish a defined airway; 4) During the operation, the rigidity of the catheter framework is finely adjusted using additional control lines to adapt to the impact of changes in surgical position on the airway; 5) After the surgery, before the patient wakes up, the skeletal part is retracted through the control line to facilitate tube removal.

[0040] Evaluation of effectiveness: The system of this invention provides a "reversible" endotracheal intubation solution, which not only ensures the airway safety of patients with difficult airways, but also reduces the difficulty of extubation and the risk of extubation-related complications.

[0041] Example 3: Pre-hospital emergency care and transport Scene description: A traffic accident victim with severe maxillofacial trauma. On-site assessment revealed airway anatomical deformation, and the patient's blood oxygen saturation continued to decline.

[0042] Operating steps: 1) Emergency responders attempted to establish an airway using a portable bronchoscope, but traditional intubation methods failed due to anatomical deformities. 2) Using the system of this invention, emergency personnel insert a fiberoptic bronchoscope with a pre-loaded compression frame into the trachea and position it. 3) In confined spaces and poor lighting conditions, the airbag module and external connector are assembled using tactile feedback through magnetic docking; 4) Pull the release line 5, and the catheter skeleton 3 expands and takes shape inside the trachea; 5) Immediately connect the transport ventilator and begin mechanical ventilation; 6) During transport, the bronchoscope has been removed and properly stored, reducing the space occupied by the equipment and facilitating patient transport.

[0043] Evaluation of effectiveness: The system of this invention achieves reliable airway establishment under harsh conditions. The miniaturization of the system components makes it easy for emergency personnel to carry and operate. The tactile feedback characteristics of the magnetic docking do not depend on ideal lighting conditions, making it suitable for pre-hospital emergency scenarios.

[0044] The working principle of this invention is as follows: Before using the system, the operator first pre-installs the radially compressed catheter frame 3 onto the outer surface of the fiberoptic bronchoscope insertion part 1 and fixes it using a restraint mechanism (not shown in the figure). The restraint mechanism can be made of biodegradable material or implemented through mechanical locking to ensure that the frame will not accidentally fall off or expand during guidance. At this time, the compressed outer diameter of the catheter frame 3 is 3-5 mm, which can smoothly pass through the glottis and bronchi at all levels.

[0045] The airbag module (including the inflatable airbag 7, the ventilation tube 8, the second magnetic component 11, etc.) and the external connector 16 are kept as independent components in a standby state and are not pre-installed on the bronchoscope.

[0046] Under bronchographic visualization, the operator inserts a bronchoscope with a compression frame through the patient's oropharynx, through the glottis into the trachea, and to the predetermined depth. During this process, the operator can observe the airway structures in real time to ensure the system accurately reaches the target location.

[0047] At this point, even if acute massive bleeding occurs and the field of vision is completely lost, the operator can continue the subsequent operation without relying on vision because the bronchoscope and compression frame are already in the correct position in the trachea.

[0048] With the bronchoscope in place, the operator holds the bronchoscope in place with one hand and slides the airbag module along the axis of the bronchoscope insertion part 1 with the other hand.

[0049] When the second magnetic traction component 11 at the distal end of the airbag module and the first magnetic traction component 6 at the proximal end of the catheter skeleton 3 approach each other, they automatically align themselves through magnetic force. This is because the first magnetic traction component 6 and the second magnetic traction component 11 employ a ring-shaped, asymmetrically arranged permanent magnet design (such as...). Figure 2 As shown, the magnetic poles are arranged in a specific sequence, generating a strong attraction force only in the single correct alignment direction, thus achieving misalignment prevention. Even within a tolerance angle of ±15°, the magnetic structure can automatically correct alignment. When the two are fully aligned, the operator can hear a clear "click" and feel a distinct tactile feedback, indicating that the alignment is complete. The alignment force is designed to be 5-10N, ensuring connection stability while allowing for manual separation if needed.

[0050] Using the same method, the operator magnetically connects the fourth magnetic component 15 at the distal end of the external connector 16 to the third magnetic component 14 at the proximal end of the airbag module. At this point, the three modules of the entire system (the tube frame, the airbag module, and the external connector) have been assembled, forming a complete endotracheal tube access. The entire assembly process can be completed within 5-10 seconds.

[0051] After assembly, the operator pulls the release line 5 to release the radial restraint on the catheter frame 3. After the restraint mechanism is released, the catheter frame 3 is no longer constrained to the outer surface of the bronchoscope insertion part 1.

[0052] Because the catheter framework 3 is made of nickel-titanium shape memory alloy, its austenitic phase transformation end temperature is set at 34°C-36°C. Therefore, upon entering the human trachea, body temperature (approximately 37°C) triggers the phase transformation process of the framework. Under the influence of body temperature, the framework gradually transforms from a radially compressed state to a preset radially expanded state, expanding in situ within the trachea to the predetermined diameter. Depending on the patient's airway diameter, specifications with expanded diameters of 7.0mm, 7.5mm, 8.0mm, or 8.5mm can be selected. The complete expansion time at body temperature is 20-40 seconds, which can be adjusted according to clinical needs.

[0053] The expanded catheter framework 3 has a mesh structure with a porosity designed to be 30%-50%. This porous structure ensures sufficient ventilation cross-section while allowing partial passage of tracheal secretions, reducing the risk of catheter blockage. The progressive expansion characteristics of the mesh framework allow it to conform to the individualized airway anatomy of the patient, reducing the shear damage caused by the "forced passage" of traditional rigid catheters.

[0054] After the tubing frame 3 is expanded and formed, the operator connects it to a ventilator or breathing bag or other respiratory support equipment through the standard 15mm interface of the external connector 16. Then, the inflatable bag 7 is inflated through the ventilation tubing 8. After the inflatable bag 7 expands, it fits tightly against the tracheal wall to achieve a tracheal seal and prevent gas leakage.

[0055] After confirming effective ventilation (which can be done by observing chest rise and fall, auscultating breath sounds in both lungs, or monitoring blood oxygen saturation), the operator smoothly withdraws the bronchoscope from the central lumen of the formed catheter. Since the catheter framework 3 has been expanded to its functional diameter, the bronchoscope can be withdrawn without obstruction. The withdrawn bronchoscope can be immediately cleaned and disinfected, ready for use on other patients or for subsequent examinations on the same patient.

[0056] The above description is merely a preferred embodiment of this utility model. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this utility model, and these improvements and modifications should also be considered within the scope of protection of this utility model. Structures, devices, and operating methods not specifically described or explained in this utility model are implemented according to conventional methods in the art, unless otherwise specified or limited.

Claims

1. A tracheal tube system for emergency airway management, characterized in that, include: The fiberoptic bronchoscope insertion section (1) is used to guide the system into the trachea under visual conditions; The catheter skeleton (3) is made of shape memory material and has a radial compression state and a radial expansion state. A first magnetic suction component (6) is provided at its proximal end. The airbag module includes an inflatable airbag (7) and an air passage (8), and a second magnetic component (11) that matches the first magnetic component (6) is provided at its distal end. Release line (5), connected to the catheter skeleton (3), is used to trigger the catheter skeleton (3) to switch from a radially compressed state to a radially expanded state; An external connector (16) is provided with a fourth magnetic component (15) at its far end, which is used to magnetically connect with the third magnetic component (14) at the near end of the airbag module.

2. The endotracheal tube system for emergency airway management according to claim 1, characterized in that: The catheter skeleton (3) is made of a mesh structure woven from superelastic nickel-titanium alloy wire, and its austenitic phase transformation end temperature (Af) is set to 34°C-36°C.

3. The endotracheal tube system for emergency airway management according to claim 1, characterized in that: The outer diameter of the catheter skeleton (3) is 3-5 mm in the radial compression state and 7.0-8.5 mm in the radial expansion state.

4. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The first magnetic attraction component (6) and the second magnetic attraction component (11) are connected to prevent misalignment through asymmetrically arranged permanent magnets, with a connection force of 5-10N.

5. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The release line (5) extends from the distal end to the proximal end of the catheter skeleton (3), and pulling the line can release the radial restraint on the catheter skeleton (3).

6. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The filling airbag (7) is designed for low pressure and high volume, and is made of medical-grade polyurethane or silicone.

7. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The external connector (16) is equipped with a standard 15mm ventilator interface.

8. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The system also includes a restraint mechanism for fixing the radially compressed catheter skeleton (3) to the outer surface of the bronchoscope insertion part (1).

9. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The porosity of the catheter skeleton (3) is 30%-50%.

10. A tracheal tube system for emergency airway management according to claim 1, characterized in that: The system also includes a connecting frame (2), a first connecting pipe (9), a connecting conduit (12), and a second connecting pipe (13) for fixing and ventilating the connections between the modules.

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